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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Record of Telephone Conversation(2), August 2, 2011 - Anascorp

 

Submission Type: BLA    Submission ID: 125335/0    Office: OBRR
Product:
Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection
Applicant:
Rare Disease Therapeutics, Inc. (RDT)
Telecon Date/Time: 02-Aug-2011 11:30 AM        Initiated by FDA? Yes
Telephone Number: (619) 328-5370 (for teleconferencing, the Firm called into the office of D. Ertel at 301-827-7121)
Communication Categorie(s):
1. Other - Post Marketing Commitments
 
Author: DONALD ERTEL
Telecon Summary:
Discussion of Post Marketing Commitments
FDA Participants: Donald Ertel, Deborah Trout
Non-FDA Participants: RDT: Jennifer Spinella, ------(b)(4)------
Trans-BLA Group: No
 
Related STNs: None
Related PMCs: None
Telecon Body:

We requested the following PMCs:
  • ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)----------------------------------------------------------------------------------------------------------------------------------------.
  • --------------------------------------------------------------------------------(b)(4)----------------------------------------------------------------------------------------.
We also requested the following written commitments:
  • ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.
  • ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.
 
Call ended at 11:40am